# K231976: StealthStation Cranial Software, v3.1.5 (9735585)

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation, Inc.
- Decided: Oct 19, 2023 after 108 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K050438 (2005). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
4 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221087: Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4, Medtronic Navigation, Inc. (2022) Summary page 5.

## Most influential descendants
- K243657: ClearPoint System (Software Version 3.0) (2025), 0 descendants of its own

## Indications for use
The StealthStation System, with StealthStation Cranial software, is intended to aid in precisely locating anatomical structures in either open or percutaneous neurosurgical procedures. The system is indicated for any medical condition in which reference to a rigid anatomical structure can be identified relative to images of the anatomy. This can include, but is not limited to, the following cranial procedures (including stereotactic frame-based and stereotactic frame alternatives-based procedures): - Cranial biopsies (including stereotactic) - Deep brain stimulation (DBS) lead placement - Depth electrode placement - Tumor resections - Craniotomies/Craniectomies - Skull Base Procedures - Transsphenoidal Procedures - Thalamotomies/Pallidotomies - Pituitary Tumor Removal - CSF leak repair - Pediatric Ventricular Catheter Placement - General Ventricular Catheter Placement

Source page: https://510kreport.com/device/K231976
Methodology: https://510kreport.com/methodology